U.S. PHARMACOPEIA

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Neomycin Sulfate and Flurandrenolide Lotion
» Neomycin Sulfate and Flurandrenolide Lotion contains the equivalent of not less than 90.0 percent and not more than 130.0 percent of the labeled amount of neomycin, and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of flurandrenolide (C24H33FO6).
Packaging and storage— Preserve in tight containers, protected from light.
Identification—
A: It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test 201BNP.
B: It meets the requirements for the Identification test under Flurandrenolide Cream.
Microbial limits 61— It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Minimum fill 755: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay for neomycin— Proceed as directed for neomycin under Antibiotics—Microbial Assays 81, using an accurately weighed portion of Lotion, equivalent to about 3.5 mg of neomycin, blended for 3 to 5 minutes in a high-speed glass blender jar containing an accurately measured volume of Buffer No. 3 sufficient to obtain a stock solution having a convenient concentration of neomycin. Dilute an accurately measured volume of this stock solution quantitatively with Buffer No. 3 to obtain a Test Dilution having a concentration of neomycin assumed to be equal to the median dose level of the Standard.
Assay for flurandrenolide— Proceed with Neomycin Sulfate and Flurandrenolide Lotion as directed in the Assay under Flurandrenolide Cream. Calculate the quantity, in mg, of C24H33FO6 in the portion of Lotion taken by the formula:
10C(rU / rS),
in which C is the concentration, in mg per mL, of USP Flurandrenolide RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1496
Pharmacopeial Forum : Volume No. 30(2) Page 516
Phone Number : 1-301-816-8223